Efficacy and Safety of a 'Graft/Prosthesis, Biomaterial (DKM410)' in the Treatment of Both Nasolabial Folds

Efficacy and Safety of a 'Graft/Prosthesis, Biomaterial (DKM410)' in the Treatment of Both Nasolabial Folds: Single Center, Prospective, Comparative, Randomized, Double Blinded (Subject, Evaluator), Matched Pairs Design, Non-inferiority, Pivotal Clinical Trial

The purpose of the study is to assess the efficacy and safety of a 'Graft/prosthesis, biomaterial (DKM410)' in the treatment of both nasolabial folds.

Study Overview

• Status: Completed
• Conditions: Nasolabial Folds
• Intervention / Treatment: Device: DKM-410; Device: Juvederm ULTRA PLUS XC 1.0ml

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Chung-Ang University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 19 years and older
2. Wrinkle Severity Rating Scale (WSRS) 3 or 4
3. Visually symmetrical bilateral nasolabial folds
4. Agreed not to use any dermatological treatment and wrinkle-improving functional cosmetics.
5. Voluntarily decided to participate in the study and signed the informed consent form
6. Willing to follow the protocol

Exclusion Criteria:

1. History of undergoing a permanent or semi-permanent filler treatment on the face
2. Received soft tissue augmentation using HA filler or collagen for nasolabial folds within 18 months from screening.
3. Received any surgery or laser treatment, chemical filling, heart attack, or Botox injection within 24 weeks from the screening
4. History of allergic reactions to Hyaluronic Acid or Gram-positive bacteria protein
5. Hypersensitivity to Lidocaine or amide local anesthetic
6. Positive for the intradermal response test
7. History of severe or plurality of allergies
8. Having skin inflammation or infection in nasolabial folds
9. History of keloid formation, hyperpigmentation, or hypertrophic scars on the face.
10. History of streptococcal disease
11. Uncontrolled epilepsy
12. Porphyria
13. Having or being currently suffering from autoimmune diseases
14. History of immunodeficiency or immunosuppressive drugs
15. History of herpetic eruption
16. Having bleeding disorder or blood clotting disorder
17. Having anticoagulant drugs or components within 72 hours from the application of medical advice
18. Received antiplatelet drugs within 2 weeks from the application of medical advice
19. Having high dose vitamin E or nonsteroidal anti-inflammatory drugs (NSAIDs) and high dose vitamin C within one week from the application of medical advice
20. Received drugs that inhibit or decrease liver metabolism
21. Clinically significant abnormalities on electrocardiogram
22. Pregnant or breast-feeding or who planning to conceive
23. Clinically severe cardiovascular, digestive, respiratory, endocrine, central nervous system disorders or mental illness
24. Other investigational products or procedures within 3 months from screening
25. Not eligible due to other reasons at the investigator's discretion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DKM-410; Participants are injected with an appropriate amount(up to 2.0ml) depending on the degree of nasolabial folds at baseline	Device: DKM-410; Injection up to 2.0ml
Active Comparator: Juvederm ULTRA PLUS XC 1.0ml; Participants are injected with an appropriate amount(up to 2.0ml) depending on the degree of nasolabial folds at baseline	Device: Juvederm ULTRA PLUS XC 1.0ml; Injection up to 2.0ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in WSRS(Wrinkle Severity Rating Scale) score by independent evaluators from Baseline to Week 24.	Independent evaluators evaluate the WSRS score change at Week 24 compared to baseline.	Baseline and Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Wrinkle Severity Rating Scale(WSRS) score by independent evaluators from Baseline to Weeks 8, 16 and 48.	WSRS(Wrinkle Severity Rating Scale) grading scale from 1 to 5, with grade 1 as absent, grade 2 as mild, grade 3 as moderate, grade 4 as severe, grade 5 as extreme.	Baseline and Weeks 8, 16 and 48.
Success rate of treatment(N%) by independent evaluators from Baseline to Weeks 8, 16, 24 and 48.	The percentage of subjects whose WSRS score was lowered by 1 or more points.	Baseline and Weeks 8, 16, 24 and 48.
Change in Wrinkle Severity Rating Scale(WSRS) score by investigator from Baseline to Weeks 8, 16, 24 and 48.	WSRS(Wrinkle Severity Rating Scale) grading scale from 1 to 5, with grade 1 as absent, grade 2 as mild, grade 3 as moderate, grade 4 as severe, grade 5 as extreme.	Baseline and Weeks 8, 16, 24 and 48.
Success rate of treatment(N%) by investigator from Baseline to Weeks 8, 16, 24 and 48.	The percentage of subjects whose WSRS score was lowered by 1 or more points.	Baseline and Weeks 8, 16, 24 and 48.
Global Aesthetic Improvement Scale (GAIS) from Baseline to Weeks 8, 16, 24 and 48.	Global Aesthetic Improvement Scale (GAIS) from -1 to 3, with grade -1 as worse, grade 0 as no change, grade 1 as improved, grade 2 as much improved, grade 3 as very much improved.	Baseline and Weeks 8, 16, 24 and 48.
Visual Analog Scale (VAS) after the treatment.	Visual Analog Scale (VAS) from 0mm to 100mm, with 0mm as no pain, 100mm as maximum pain.	Baseline

Collaborators and Investigators

• Sponsor: Dongkook Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2021
• Primary Completion (Actual): January 14, 2022
• Study Completion (Actual): June 28, 2022

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: November 7, 2022
• First Posted (Actual): November 10, 2022

Study Record Updates

• Last Update Posted (Actual): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 9, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: DKM-410-MD-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No